Ex Parte Anzali et al

Patent Trial and Appeal Board

Dec 28, 2016

13657312 (P.T.A.B. Dec. 28, 2016)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/657,312 10/22/2012 Soheila ANZALI MERCK-3826-D01 5489
23599 7590 12/30/2016
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/30/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SOHELIA ANZALI, FRANCIS CONTARD, and
JEAN JACQUES ZEILLER* 1
Appeal 2016-000830
Application 13/657,312
Technology Center 1600
Before DONALD E. ADAMS, ELIZABETH A. LaVIER, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for using indole compounds as a cosmetic which have been rejected
as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as Merck Patent GMBH. Br.
1.
Appeal 2016-000830
Application 13/657,312
STATEMENT OF THE CASE
The present invention is directed to the use of indole compounds in
compositions, especially topical, cosmetic and/or personal care
compositions. Spec 1.
Claims 1—10 and 12—18 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A method for the cosmetic application of a
composition, comprising cosmetically applying said
composition to a subject,
or
a method for treating a skin disease selected from the group
consisting of skin diseases which are associated with defective
keratinisation relating to differentiation and cell proliferation,
acne vulgaris, acne comedonica, polymorphic acne, acne
rosaceae, nodular acne, acne conglobata, age-related acne, acne
occurring as a side effect, acne Solaris, medicament-related
acne, acne professionalis, defects of keratinisation, ichthyosis,
ichthyosiform states, Darier’s disease, keratosis palmoplantaris,
leukoplakia, leukoplakiform states, skin and mucosal (buccal)
eczema (lichen), skin diseases which are associated with
defective keratinisation and have an inflammatory and/or
immunoallergic component, psoriasis relating to the skin,
mucous membranes and finger- and toenails, psoriatic
rheumatism, skin atopy, eczema, respiratory atopy, and
hypertrophy of the gums, comprising applying a composition in
an effective amount to a subject in need thereof,
or
a method for hair care and/or hair follicle development,
comprising applying a composition in an effective amount to a
subject in need thereof,
or
a method for the care, preservation or improvement of the
general state of the skin or hair,, [sic] comprising applying a
composition in an effective amount to a subject in need thereof,
or
2
Appeal 2016-000830
Application 13/657,312
a method for skin lightening and/or skin whitening, comprising
applying a composition in an effective amount to a subject in
need thereof,
or
a method for reducing skin unevenness, wrinkles, fine lines,
rough skin or large-pored skin, comprising applying a
composition in an effective amount to a subject in need thereof,
or
a method for reducing harm fill effects of UV rays on the skin,
comprising applying a composition in an effective amount to a
subject in need thereof,
wherein the composition, comprises
a compound of formula of I
wherein
R1, R2 and R3 are identical or different and each is H or alkyl of
1-6 carbon atoms,
R4 is H or methyl,
R5 is phenyl or chlorophenyl,
and/or physiologically acceptable salts thereof
and one or more topically acceptable vehicles.
The claims stand rejected as follows:
Claims 1—5, 7—10 and 12—15 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Schacht.2
2 Schacht et al., US 4,069,338, issued Jan. 17, 1978 (“Schacht”).
R;
O
3
Appeal 2016-000830
Application 13/657,312
Claims 6 and 16—18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Schacht in view of Gainer.3
THE ANTICIPATION REJECTION
Issue
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 1—5, 7—10 and
12—18 are anticipated by Schacht under 35 U.S.C. § 102(b).
The Examiner finds that Schacht teaches compositions comprising an
indole derivative with the formula
Final Act. 2.
The Examiner finds that Schacht teaches that the composition can be
applied topically. Final Act. 3. The Examiner finds that the patient
population of Schacht would be in need to treatment against skin aging. Id.
The Examiner concludes that “[t]he prior art is anticipatory insofar as it
teaches application of a composition comprising a compound of formula I
and one or more topically acceptable vehicles to a patient in need thereof.”
Id.
Appellants contend that Schacht only teaches the use of indole
compounds for the treatment of high cholesterol and that a patient in need of
3 Gainer, US 2009/0110746, published Apr. 30, 2009 (“Gainer”).
4
Appeal 2016-000830
Application 13/657,312
lowering cholesterol is not necessarily in need of treatment of a skin
disorder. Appeal Br. 9. Appellants also argue that topical application of the
indole compound is only one of many different modes of application taught
by Schacht, and that the Examiner’s rejection relies on improper picking and
choosing. Appeal Br. 8—9.
Findings of Fact
FF1. Schacht discloses the use of indole compounds having the
formula
to reduce cholesterol. Schacht Abstract.
FF2. Schacht teaches that the indole compounds can used or mixed
with excipients suitable for “enteral, parental or topical administration.”
Schacht col. 6,11. 23—28.
FF3. Schacht teaches that the indole compounds can be incorporated
into ointments, creams or powders for topical applications. Schacht col. 6,
11. 37-38.
FF4. Schacht teaches that compositions containing the indole
compounds “can contain one or more additional active compounds, for
example vitamins.” Schact col. 6,11. 45^46.
5
Appeal 2016-000830
Application 13/657,312
Principles of Law
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
“[AJnticipation does not require actual performance of suggestions in
a disclosure. Rather, anticipation only requires that those suggestions be
enabled to one of skill in the art.” Impax Labs., Inc. v. Aventis Pharms. Inc.,
468 F.3d 1366, 1382 (Fed. Cir. 2006) (quoting Bristol-Myers Squibb Co. v.
Ben Venue Labs., Inc., 246 F.3d 1368, 1378 (Fed. Cir. 2001)).
Analysis
We agree with the Examiner that claim 1 is anticipated by Schacht.
Schacht teaches the topical application of indoles having the same formula
as recited in claim 1. FF1—3. While Schacht teaches that other
administration routes are preferred, that does not negate the specific teaching
of topical application.
Appellants argue that topical application is not the same as
“cosmetically applying” recited in claim 1. Reply Br. 3^4. We are
unpersuaded. We agree with the Examiner that Schacht’s teaching of topical
application embraces cosmetically applying. Ans. 5. Moreover, Appellants
have offered only attorney argument to support the position that topically
applying does not embrace cosmetically applying. “Attorneys’ argument is
no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581
(Fed. Cir. 1989).
We also agree with the Examiner that claim 5 is anticipated. Claim 5
adds the limitations to claim 1 that the composition contain at least one
6
Appeal 2016-000830
Application 13/657,312
further skin-care ingredient and at least one carrier which is suitable for
topical applications. Appeal Br. 25 (Claims Appendix). Schacht teaches the
use of excipients suitable for topical application and that the compositions
can also include other active ingredients such as vitamins. Final Act. 3; FF2
and 4.
With respect to claims 7, 9, 10, and 12—15, we reach a different
conclusion. We agree with Appellants that Schacht does not teach the use of
the claimed indole compounds for the specific applications recited in
Appellants’ method claims. See Appeal Br. 17—22. While Schacht teaches a
method for cosmetic, i.e. topical, application as called for in claim 1,
Schacht only teaches the use of the composition for the treatment of high
cholesterol. FF1. Absent a clear teaching to use the indole containing
compositions for the specific applications recited in claims 7, 9, 10, and 12—
15, there can be no anticipation. Rapoport v. Dement, 254 F.3d 1053, 1061
(Fed. Cir. 2001).
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1 and 5 are anticipated by Schacht under 35 U.S.C.
§ 102(b), but that the Examiner has not established by a preponderance of
the evidence that claims 7, 9, 10, and 12—15 are anticipated by Schacht.
Claims 2-4, and 8 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
7
Appeal 2016-000830
Application 13/657,312
THE OBVIOUSNESS REJECTION
Issue
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 6 and 16—18 are
unpatentable over Schacht combined with Gainer under 35 U.S.C. § 103(a).
As discussed above, the Examiner finds that Schacht teaches the
topical application of the claimed indole compounds for the treatment of
high cholesterol and would be useful for treating atherosclerosis. Final Act.
2. The Examiner finds that Gainer teaches the use of ectoine to enhance
oxygen diffusion and treat atherosclerosis. Final Act. 4. The Examiner
concludes that
it is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same
purpose in order to form a third composition that is to be used
for the very same purpose; the idea of combining them flows
logically from their having been individually taught in prior art.
See MPEP 2144.06. Thus, combining the indole compounds of
Schacht et al. with the ectoine as claimed in the instant
invention would have been prima facie obvious since they are
both taught to be useful for treating atherosclerosis.
Id.
Appellants contend that Schacht does not teach the use if the indole
compounds to treat atherosclerosis. Appeal Br. 6. Appellants argue that
ectoine is only mentioned once in Gainer as one of many different
compounds that can be used to improve oxygen diffusion. Appeal Br. 11—
13. Appellants also argue that Gainer teaches that the compounds can be
used to treat a number of different disorders and can be used in a number of
8
Appeal 2016-000830
Application 13/657,312
different forms. Appeal Br. 13—15. Appellants argue that the references do
not teach the use of the two compositions together and that there is no
motivation to combine the references. Appeal Br. 15—17.
Findings of Fact
FF5. Gainer teaches the use of ectoine as a diffusion enhancing
compound. Gainer 139.
FF6. Gainer teaches that the diffusion enhancing compounds can be
used to treat atherosclerosis. Gainer | 55.
FF7. Gainer teaches that the diffusion enhancing compounds can be
incorporated into formulations for topical administration. Gainer 148.
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRIntl Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[W]henthe
question is whether a patent claiming the combination of elements of prior
art is obvious,” the answer depends on “whether the improvement is more
than the predictable use of prior art elements according to their established
functions.” KSRIntl Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. . . . [A]ny need or problem known in the field of endeavor
at the time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” Id. at 419—20.
To show criticality of a claimed range:
9
Appeal 2016-000830
Application 13/657,312
“[I]t is not inventive to discover the optimum or workable
ranges by routine experimentation.” In reAller, 220 F.2d 454,
456 (CCPA 1955). Only if the “results of optimizing a
variable” are “unexpectedly good” can a patent be obtained for
the claimed critical range. In re Antonie, 559 F.2d 618,
620(CCPA 1977).
In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997).
Analysis
Claim 6 is representative of the rejected claims and is directed to
topically applying a composition comprising an indole derivative and
ectoine.
We agree with the Examiner that the subject matter of claim 6 would
have been obvious to one skilled in the art at the time the invention was
made. Schacht teaches the topical application of indole derivatives to lower
cholesterol. FF1 4. As the Examiner points out, lowering cholesterol is
useful in treating atherosclerosis, which is characterized by the build-up of
cholesterol containing plaque in the walls of the artery. Ans. 7. Gainer
teaches the use of ectoine to treat atherosclerosis. FF5 and 6. We agree with
the Examiner that it would have been obvious to one skilled in the art to use
both the claimed indole derivatives and ectoine to treat atherosclerosis.
With respect to claims 16—18, we agree with the Examiner that
determining the amounts of ectoine to be used in the composition would
have been a matter of routine optimization. Ans. 8.
Appellants argue that the applications taught by Gainer and Schacht
are significantly different that those recited in the instant claims and that one
skilled in the art would not have been lead to optimize the amounts or
ectoine based on the teachings of the references. Reply Br. 6—7. We are
10
Appeal 2016-000830
Application 13/657,312
unpersuaded. As the Examiner points out, Appellants have offered no
evidence that the claimed ranges of ectoine are critical. Ans. 8. Moreover,
Appellants have offered only attorney argument to support the proposition
that one skilled in the art would not have arrived at the claimed amounts of
ectoine.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 6 and 16—18 would have been obvious over Schacht
combined with Gainer under 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejection of claims 1—5 and 8 under 35 U.S.C. § 102(b).
We reverse the rejection of claims 1,9, 10, and 12—15 under 35
U.S.C. § 102(b).
We affirm the rejection of claims 6and 16—18 under 35 U.S.C.
§ 103(a).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
11